Kornimate/medical-research-clean huggingface dataset:
cardiovascular function and physical activity in covid-19

Conditions: Coronavirus 2019

Summary: the purpose of this study is to a) assess how coronavirus 2019 (covid-19) affects cardiac function in middle age and older adults and b) assess if a physical activity intervention (increased daily step count by 2,000) can affect cardiac function in a population with a history of covid-19.

cardiac function will be assessed by obtaining arterial stiffness, comprehensive echocardiography measurements and haemodynamic monitoring. arterial stiffness will assess primarily pulse wave velocity (pwv) and echocardiography. graded cardiopulmonary exercise stress testing coupled with non-invasive gas exchange and haemodynamic monitoring will also be performed. physical activity will be assessed objectively using pedometers and accelerometry. quality of life, sleep/ circadian rhythm, fatigue, anxiety and depression will be measured using the validated short-form-36 (sf-36) questionnaire, pittsburgh sleep scale (psqi), chalder fatigue (cf) scale and the depression, anxiety and stress scale (dass-21).

Eligibility criteria:
inclusion criteria: * between 50-85 years old * up to date with all covid-19 vaccinations * covid participants - had a positive test for covid-19 over 28 days of initial visit but before 18 months. non-covid participants - never received a positive covid-19 test result, and no symptoms during periods where testing was unavailable. exclusion criteria: * chronic respiratory and cardiovascular conditions i.e., chronic obstructive pulmonary disease (copd), emphysema, pulmonary hypertension, coronary artery disease * severe hypertension * acute or chronic neurological impairment or progressive neurological disease * use of medication known to directly affect cardiac function * current smoker * body mass index \> 35 kg/m2 * people who exceed current physical activity guidelines defined by the world health organization (who).

Keywords: coronavirus 2019 cardiovascular system arterial stiffness echocardiography cardiopulmonary exercise stress testing covid-19
a study of safety and efficacy of nivolumab and bendamustine (nb) in patients with relapsed/refractory hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: a clinical study of safety and efficacy of treatment with nivolumab and bendamustine (nb) in patients with relapsed/refractory hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * diagnosis: histologically confirmed hodgkin's lymphoma * relapsed or refractory to at least two prior treatment lines * relapsed after nivolumab treatment or refractory to nivolumab treatment * age 18-70 years old * signed informed consent * no severe concurrent illness exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent * active or prior documented autoimmune disease requiring systemic treatment.

Keywords: hodgkin's lymphoma nivolumab bendamustine hydrochloride
sofosbuvir/velpatasvir in adults with chronic hepatitis c virus infection who are on dialysis for end stage renal disease

Conditions: Chronic Hepatitis C

Summary: the primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (sof/vel) for 12 weeks in adults on dialysis for end stage renal disease (esrd) with chronic hepatitis c virus (hcv) infection of any genotype.


Eligibility criteria:
key inclusion criteria: * chronic hcv infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for esrd, including adults with hiv co-infection if they are suppressed on a stable, protocol-approved antiretroviral (arv) regimen for ≥8 weeks prior to screening. note: other protocol defined inclusion/ exclusion criteria may apply.
novel association of cholesterol ester storage disease due to lysosomal acid lipase deficiency and non-alcoholic fatty liver disease: a prospective clinical study

Conditions: Non-alcoholic Fatty Liver Disease; Cholesterol Ester Storage Disease

Summary: non-alcoholic fatty liver disease (nafld) is a world-wide problem with a global prevalence estimated at 1.5 billion people. it is characterised by significant diversity and phenotypic heterogeneity. morbidity rates are estimated at 20% to 30% in western adults, increasing to 90% in patients who are morbidly obese or diabetic. risk factors in non-obese nafld patients are of especial practical and theoretical importance. cholesterol ester storage disease (cesd) is an autosomal recessive chronic disease of variable phenotype, caused by a deficiency in lysosomal acid lipase (lal) and characterized by accumulation of fat in tissues and organs. hepatic accumulation of fat in this disorder can cause hepatomegaly with varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and isolated splenomegaly. since the contribution of lal deficiency to non-obese nafld is poorly understood, the investigators propose to evaluating the association between nafld and lal deficiency in a prospective study in our population.


Eligibility criteria:
inclusion criteria: * age between 18-80 years; * bmi 25-40; * fatty liver disease (bright liver, hepatomegaly by ultrasound (liver span \> 15 cm mid clavicle line), splenomegaly (\>13 cm) or both. exclusion criteria: * alcohol abuse\>30 gm/day, or \> 70 gram per week; * soft drink abuse; * drugs known to cause fatty liver; * chronic hepatitis (b and c); * biliary liver disease; * autoimmune hepatitis; * hiv; * genetic/metabolic liver disease (wilson, alpha-1 antitrypsin, cf); * failure to give informed consent
physical exercise to reduce anxiety in underserved children with asd

Conditions: Physical Exercise Condition; Control Condition

Summary: anxiety is one of the most frequent comorbidities in children with asd leading to poor clinical outcomes. physical exercise has been shown to be a promising and easy to implement intervention for reducing anxiety. however, little is known about the feasibility and efficacy of physical exercise to reduce anxiety in children with asd from underserved, low-income families. children with asd, ages 6 - 12 years old from low-income and latino families will be recruited for the study and assigned to an exercise intervention group and a sedentary control group. the physical exercise program is an eight-week program, administered three times per week in small groups. compliance, parent-rated anxiety, and salivary cortisol will be measured before and after completion of the exercise and control group interventions.


Eligibility criteria:
inclusion criteria: * autism spectrum disorder (asd) diagnosis 6-12 years old * ≥ 93rd percentile on cbcl or total score of ≥ 25 on scared * able to attend 3x/week for 8 consecutive weeks * able to follow instructions * caloptima insurance or medicaid and ability to participate in moderate physical exercise exclusion criteria: * danger to themselves or others * medical conditions that may pose a risk during exercise * unable to participate in moderate physical exercise * joining a regular physical exercise program in the last 4 weeks or planning to start or discontinue a regular physical exercise program in the next 8 weeks * unable to attend 3x/week for 8 consecutive weeks * visual, auditory or motor impairments, which would preclude participation in study activities
2nd international survey on interventional strategies

Conditions: Coronary Artery Disease

Summary: the study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.

2nd international survey on interventional strategies is a web-based platform. the survey contains specific questions and dedicated case presentations on two major topics. the first part queries the characteristics of the participants, including overall experience in interventional cardiology, annual volume of percutaneous coronary intervention (pci), and duration of experience with quantitative coronary angiography (qca), intravascular ultrasound (ivus),optical coherence tomography (oct), fractional flow reserve (ffr) and non-hyperaemic pressure ratios (nhpr). the survey uses here predefined categories and single-choice questions. the second part investigates personal strategies for evaluating angiographically intermediate stenoses in the catheterization laboratory. here, participants are asked to evaluate 5 complete coronary angiograms. all cases are characterised as stable angina without relevant changes on resting ecg. no information about non-invasive testing is known or provided. here participants are asked to (1) localise all relevant stenoses by indicating the involved segment; (2) define percent diameter stenosis (%ds) by visual estimate; and (3) determine the significance of the stenosis of interest. in cases of angiographic uncertainty, the preferred diagnostic tool is asked to be selected from the arsenal available in the catheterisation laboratory, namely qca, ivus, oct, ffr or nhpr. participants are asked to make their decisions assuming ideal world conditions, without considering any financial restrictions or local regulations, but only after the best clinical practice achievable in this virtual catheterisation laboratory.

Eligibility criteria:
inclusion criteria * interventional cardiologists * interventional cardiologists in training
high flow nasal oxygen therapy for hypoxemy after cardiac surgery

Conditions: Hypoxemic Acute Respiratory Failure

Summary: the main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.


Eligibility criteria:
inclusion criteria: * patient with indication of coronary artery bypass * absence of preoperative respiratory failure * hypoxia after extubation defined as spo2 \< 96% with venturi mask 50% 8l/min * age \> 18 years * signed informed consent exclusion criteria: * patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders * hemodynamic instability, low flow rate * pneumothorax or hemothorax * bleeding major, ischemic signs * ventricular arrhythmia * respiratory failure * non controlled hyperalgia * alteration of mental status * cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery * pregnancy * major under guardianship

Keywords: cardiac surgery acute respiratory failure high flow oxygen therapy
patellar resurfacing versus patellar retention in total knee arthroplasty - a randomized clinical trial

Conditions: Total Knee Replacement

Summary: background: despite the excellent results of total knee replacement, also known as total knee arthroplasty (tka) there is persistent controversy over whether or not to replace the surface of the kneecap. anterior knee pain, which occurs with variable and unpredictable frequency, continues to be a problem in a subset of tka patients. some clinicians replace the surface of all kneecaps during tka to avoid repeat surgery, which occurs in approximately 10% of cases. however, others cite the complications attributed to replacing the surface of kneecap as reasons to avoid this procedure. this study prospectively randomized patients receiving tka into two groups, those receiving replacement of the kneecap surface and those left without replacement of the kneecap surface to determine clinical outcomes and revisions over the first 5-10 postoperative years. objectives: the primary objective of this work was to compare pain, stiffness and function between groups at five years postoperatively. secondarily, we compared pain, stiffness and function at one and 10 years postoperatively. finally, we examined the number of reoperations following tkr over 10 years in the 2 groups of subjects. the investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes. methods: patients receiving tka were prospectively enrolled before surgery and randomized intraoperatively to either receive a replacement of the kneecap surface or have no kneecap intervention. the smith and nephew profix tka system was implanted in all cases; the post-operative regimen was standardized. subjects were assessed pre-operatively and at 1 and 5 years postoperatively for pain, function, and stiffness using a disease-specific (western ontario and macmaster osteoarthritis index \[womac\]) and generic health status (short form 36 \[sf-36\]) questionnaire. at the end of the five year follow-up, the study was extended to a 10-year followup and the same outcomes were assessed. the revision rate was also compared between the two groups at the end of the 10-year follow-up.


Eligibility criteria:
inclusion criteria: * scheduled for primary tka to treat non-inflammatory arthritis * age 40- 75 years of age exclusion criteria: * history of knee sepsis * previous patellectomy * previous high tibial osteotomy * knee flexion contracture of \>20 degrees * varus or valgus deformity of \> 20 degrees * \< 90 degrees of knee flexion * tibial or femoral bone deficiency requiring augmentation

Keywords: total knee replacement patellar resurfacing health related quality of life
ambu auragain vs lma supreme in laparoscopic surgery

Conditions: Laparoscopy; Airway Management; Supraglottic Airway Devices

Summary: the aim of the study is to compare the performance of two supraglottic airway devices (sga), the new ambu auragain and the lma supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position. primary outcome is the airway seal pressure. secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.

the patients are randomly assigned to 2 groups: * group 1: ambu auragain. * group 2: lma supreme, teleflex procedure: the investigation protocol contains the following sections: 1. induction of anaesthesia. intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). no muscle relaxant will be used for insertion of the sga. rocuronium 0.2 mg/kg will be administered before initiation of pneumoperitoneum. 2. insertion of the sgas. the size of the sga device used is based on the manufacturers' recommendations. all devices are deflated a lubricated prior to use. once inserted, the cuff is be inflated with a manometer up to 60 cm h20 position of the device is adjusted if needed. data recorded: size of sga, time an number of attempts. 3. fibreoptic evaluation of the sgas anatomical position: complete view of the vocal cords (i), epiglottis visible inside, but not causing obstruction (ii), epiglottis visible and obstructing the glottic inlet (iii), or glottic structures not identified (iv). 4. functionality of the gastric drainage channel of the sgas: passage of a 16 g size tube. 5. measurement of airway seal pressure (oropharyngeal leak pressure (olp): at baseline, and at 15, 30 and 60 minutes. the maximum pressure allowed is 40 cm h2o. 6. ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes. perioperative complications: hiccup, gastric distension, regurgitation / aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (spo2 \< 92%) 7. removal of the sgas: presence of blood - 3 level grading (+/++/+++) postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale

Eligibility criteria:
inclusion criteria: * patients evaluated as eligible for a sga * asa i-iii * without criteria for difficult airway * body mass index ≤ 35 kg/m2 * the patient has signed the informed consent * the patient understands his or hers rights and consequences related to this investigation exclusion criteria: * planned operation time \> 2 hours * high risk of regurgitation * respiratory tract pathology * preoperative sore throat * patients with a known or predicted difficult airway * patients diagnosed with dementia or any mental handicaps * patient who has a guardian.
post-operative radiation with imrt in the management of stage iib-iii breast cancer

Conditions: Breast Cancer

Summary: research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage iib-iii breast cancer. the current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (ht-imrt), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage iib-iii breast cancer.

the role of locoregional radiation therapy in the management of stage iib and iii breast cancer has evolved and continues to evolve. the exact role of locoregional radiation, including axillary, supraclavicular and internal mammary nodes is, however, not clear. radiation-induced toxicity remains a limiting factor to expanding the indications for radiation therapy to axillary and internal mammary nodes in the treatment of stage iib and iii breast cancer. excellent target coverage and normal tissue sparing of imrt has been previously demonstrated dosimetrically and clinically. in this feasibility study, patients will receive 50 gy of radiation therapy in 25 fractions to the chest wall and supraclavicular, axillary and im nodal areas using ht-imrt following breast conserving surgery or mastectomy and chemotherapy. patients will also be eligible for a radiation boost to 12 gy by ht-imrt or hdr brachytherapy. it is expected that treatment with ht-imrt will result in appreciably fewer side-effects following locoregional irradiation due to a reduction in normal tissue irradiation, as compared to conventional radiation therapy.

Eligibility criteria:
inclusion criteria: 1. surgery with either mastectomy or breast conserving surgery 2. presence and association of any of the following high risk pathological features present at time of surgery: stage pt3-4 and pn0 and central/medial location of tumour or any pt and pn2 (stage iib-stage iii) 3. all patients will have been treated previously with chemotherapy prior to radiation therapy 4. ecog performance status of 2 or less exclusion criteria: 1. prior chest wall/breast or nodal radiation for other malignancies (i.e. hodgkin disease) 2. her2+ positive patients 3. patients with diagnosis of metastatic disease 4. prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of breast cancer

Keywords: breast cancer locoregional imrt tomotherapy
upset stomach relief for mild and moderate indigestion and heartburn

Conditions: Indigestion; Heartburn

Summary: the primary hypothesis of the present study is that supplementation with the upset stomach relief test product will reduce the severity of the symptoms of occasional indigestion and heartburn.

the purpose of the present study is to evaluate 1) the impact of the test product on symptoms of occasional indigestion and heartburn in 200 adult participants who suffer from occasional indigestion and heartburn and 2) the subjective experience of these participants related to general health, indigestion and heartburn symptoms, and personal experience with the test product. while dietary and lifestyle changes can ease the symptoms of indigestion and heartburn, hlnatural, inc. created the test product to reduce occasional indigestion and heartburn. the test product is a plant-based remedy formulated with ingredients that have demonstrated efficacy reducing symptoms associated with occasional indigestion and heartburn.

Eligibility criteria:
inclusion criteria: * adult candidates who are in overall good health but who suffer from the symptoms of indigestion. * participants will be deemed to be in good health if they do not report any of the existing medical conditions asked about in the screening questionnaire. exclusion criteria: * age \<18 years old. * unwilling to take test product for their symptoms. * are not able to swallow pills. * allergy to any of the following: licorice, artichoke leaf, marshmallow root, ginger, chamomile, cellulose capsule, rice hull concentrate, carrageenan. * has any of the following medical conditions: * has had an ulcer * has been diagnosed with a digestive disorder * diagnosed with gastroesophageal reflux disorder * participants with diagnosed with irritable bowel syndrome * participants with active hp infection or with gastric or duodenal ulcer * participants who have been prescribed any medication by their physician for any gi disorder or medication that can affect the gi system. * participants with previous diagnosis of cancer or with previous surgery of the upper gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy) * pregnant women or breastfeeding. * alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion * participant who scores a 0, 3, or 4 on the dyspepsia symptom severity index * participants who are currently using anticoagulation medications daily. (aspirin, coumadin, heparin etc.)

Keywords: natural supplement
study of fampridine-sr tablets in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the purpose of the study is to show that individuals treated with fampridine-sr tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.

multiple sclerosis (ms) is a disorder of the body's immune system that affects the central nervous system (cns). normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. in people with ms, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. as a result, patients with ms may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. these periods of illness may come (exacerbations) and go (remissions). fampridine-sr is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with ms. this study will evaluate the effects and possible risks of taking fampridine-sr in ms patients

Eligibility criteria:
inclusion criteria: * patient with clinically defined multiple sclerosis * all patients must be able to complete two trials of a timed 25 foot walk exclusion criteria: * female patients who are either pregnant or breastfeeding.

Keywords: multiple sclerosis ms walking leg strength demyelination